OR WAIT null SECS
July 08, 2024
Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.
July 03, 2024
Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.
A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.
June 29, 2024
The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.
June 27, 2024
Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.
June 26, 2024
Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.
June 24, 2024
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
June 20, 2024
Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.
June 10, 2024
The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.